GLICLAZIDE TABLETS 80MG

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE
USER

Gliclazide 80mg Tablets
BP
(Gliclazide)

Read all of this leaflet carefully before you
start taking this medicine.
●Keep this leaflet. You may need to read it again.
●If you have any further questions, ask your
doctor or pharmacist.
●This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
●If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Gliclazide tablets are and what they are
used for
2. Before you take Gliclazide tablets
3. How to take Gliclazide tablets
4. Possible side effects
5. How to store Gliclazide tablets
6. Further information

1. WHAT GLICLAZIDE TABLETS
ARE AND WHAT THEY ARE
USED FOR
Gliclazide is a oral anti-diabetic drug belonging to
a group of medicines called sulphonylureas . It
acts by reducing the blood sugar levels in the
body.
Gliclazide is used for the treatment of Type 2
(non-insulin dependent) diabetes mellitus
particularly where diet and exercise changes
alone have not been sufficient to control it. In
type 2 diabetes, there is too much sugar
(glucose) is in your blood because your pancreas
does not produce enough insulin or because it
produces insulin that does not work properly.

2. BEFORE YOU TAKE GLICLAZIDE
TABLETS
Do not take Gliclazide Tablets if :
●you are allergic (hypersensitive) to gliclazide or
any of the other ingredients of Gliclazide Tablets
(see section 6).
●you are allergic to other medicines of the same
group (sulphonylureas), or to other related
medicines (hypoglycaemic sulphonamides).
●you are breastfeeding (see section ‘‘Pregnancy
and breastfeeding’’).
●you have insulin-dependent diabetes (type
1)you have ketone bodies and sugar in your
urine (this means you have diabetic
keto-acidosis), a diabetic pre-coma or coma.
●you are diabetic and undergoing surgery, after
trauma or during serious infections
●you have severe kidney or liver disease.
●you take miconazole (for fungal infections).
●have porphyria (a hereditary disease affecting
the liver or bone marrow).
●you have rare hereditory problems of galactose
intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption.
Gliclazide tablets are not recommended for use
in children.
If you think any of these situations applies to you,
or if you have any questions or doubts about
taking Gliclazide Tablets, then you should consult
your doctor or pharmacist.
Take special care with Gliclazide Tablets
Please check with your doctor or pharmacist
before taking Gliclazide tablets if you:
●have liver or kidney problems.
●have an inherited condition where your red
blood cells don’t produce enough of the enzyme
G6PD (glucose 6 phosphate dehydrogenase).
●suffer from particular hormone-induced
disorders (functional disorders of the thyroid
gland, of the pituitary gland or adrenal cortex)
●are at risk of developing low blood sugar
(hypoglycaemia) - take meals irregularly or skip
meals altogether, are fasting, malnourished,
change your diet, increase your physical activity
and carbohydrate intake does not match this
increase, drink alcohol, especially in
combination with skipped meals
●take other medicines or natural remedies at the
same time
●take too high doses of gliclazide
You should observe the treatment plan
prescribed by your doctor to achieve proper
blood sugar levels. This means, apart from
regular tablet intake, you observe the dietary
regimen, have physical exercise and, where
necessary, reduce weight.
During gliclazide treatment regular monitoring of
your blood (and possibly urine) sugar level and
also your glycated haemoglobin (HbA1c) is
necessary.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
The treatment of your diabetes with Gliclazide
Tablets may be affected by a number of other
medicines you may have been prescribed or
have bought from the chemist.
In particular, tell your doctor if you are taking
any of the following:
The following medicines may enhance the blood
sugar lowering effect of this medicine and
therefore increase the chance of low blood sugar
(hypoglycaemia). If you start treatment with any
of these your dose of Gliclazide Tablets may
therefore need to be decreased:
●Medicines to treat high blood pressure or heart
failure or irregular heart beats (ACE inhibitors,
Beta-blockers, Antiarrhythmics e.g. captopril,
enalapril, propranolol, disopyramide).
●Medicines to treat ulcers in the stomach or
duodenum (Antiulcers e.g. cimetidine).
●Medicines used to reduce high blood fat levels
(Lipid lowering agents e.g. clofibrate).

●Medicines to treat depression (MAOI
antidepressants, e.g. phenelzine).
●Medicines to treat fungal infections (Antifungals
e.g. miconazole, fluconazole).
●Other medicines used to treat high blood sugar
(Oral antidiabetics, GLP-1 receptor or insulin).
● Painkiller (including non steroidal
anti-inflammatory drugs) or antirheumatics (e.g.
phenylbutazone, azapropazone,ibuprofen,
aspirin).
●Sulphonamide antibiotics, e.g.
sulfamethoxazole, co-trimoxazole.
●• Antibacterials including clarithromycin,
tetracycline compounds, oral forms of
miconazole (see section 2), trimethoprim and
chloramphenicol.
●Alcohol or medicines containing alcohol.
●Hormones such as testosterone or octreotide
●Medicines used to treat gout (e.g.
sulfinpyrazone).
●Medicines used to treat breast or prostate
cancer (e.g.aminoglutethimide).
●Thyroid hormones used to treat thyroid
problems e.g. thyroxine.
The following medicines may increase blood
glucose levels. If you start treatment with any of
these your dose of Gliclazide Tablets may
therefore need to be increased:
●Medicines to treat disorders of the central
nervous system (Antipsychotics e.g.
chlorpromazine, olanzapine).
●Medicines reducing inflammation (Corticosteroids,
e.g. hydrocortisone, prednisolone).
●Medicines to treat asthma or used during labour
(intravenous salbutamol, ritodrine and
terbutaline).
●Medicines to treat breast disorders, heavy
menstrual bleeding and endometriosis
(danazol).
●Medicines which increases urine flow (Diuretics,
especially thiazide diuretics, e.g.
bendroflumethiazide).
●Oral contraceptives e.g. oestrogens and
progesterones.
●Rifamycins (antibacterial medicine)
●Laxatives used for constipation e.g. magnesium
hydroxide.
●Adrenocorticotropic hormones (ACTH) used in
the treatment of adrenal insufficiency of central
origin.e.g. tetracosactrin.
Gliclazide Tablets increases the effect of
medicines which reduce blood clotting
(Anticoagulants, e.g. warfarin).
The effect of gliclazide may be diminished when
taken along with Diazoxide (for high blood
pressure).
The effect of gliclazide may be reduced when
taken along with Lithium (to treat mental health
problems) and nifedipine (to treat high blood
pressure).
Taking Gliclazide Tablets with food and drink
Gliclazide Tablets should be taken before food ,
either with breakfast or the first main meal of the
day. Drinking alcohol can alter the control of your
treatment for diabetes and should be avoided.
If you have any questions or doubts about taking
Gliclazide Tablets, you should consult your doctor
or pharmacist.
Pregnancy and breast-feeding
Gliclazide Tablets is not recommended for use in
pregnancy. If you are pregnant, or planning to
become pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby while
taking this medicine, inform your doctor so that he
may prescribe a more suitable treatment for you.
You must not take gliclazide tablets while you are
breast feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Provided your blood glucose levels are satisfactorily
controlled on Gliclazide tablets, your ability to drive
or use machines should not be affected.
However, if your blood glucose levels become too
low, this could adversely affect your concentration,
and therefore your ability to perform these tasks.
Ask your doctor whether you can drive a car if you:
●have frequent episodes of low blood sugar
(hypoglycaemia),
●have few or no warning signals of low blood
sugar (hypoglycaemia).
Important information about some of the
ingredients of Gliclazide Tablets
Gliclazide Tablets contains lactose. If your doctor
has told you that you have intolerance to some
sugars contact your doctor before taking this
medicine.

3. HOW TO TAKE GLICLAZIDE
TABLETS
Always take Gliclazide Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dose is as mentioned below:
Adults :
The total daily dose may vary from one half to
four tablets daily taken orally. The dose may be
increased by your doctor if your blood sugar level
does not come down enough. You should not
take more than two tablets at a time. When
higher dose is required, you will be given
Gliclazide tablets in divided doses twice a day.
Elderly:
The total daily dose may vary from one half to
four tablets daily taken orally. The dose may be
increased by your doctor if your blood sugar level
does not come down enough. You should not
take more than two tablets at a time. When
higher dose is required, you will be given
Gliclazide tablets in divided doses twice a day.
Extra care is required due to a possible
age-related increased risk of hypoglycaemia.
Obese: Additional therapy may also be required.
Children
Gliclazide tablets should not be used in
children.

Kidney and Liver disorders:
The starting dose should be 40mg daily (1/2
tablet) increasing until adequate control is
achieved.
These tablets should be taken as instructed,
followed by a glass of water before meals. You
should continue to take these tablets for as long
as your doctor tells you to.
Treatment for diabetes is usually life-long.
If you take more Gliclazide Tablets than you
should
If you or someone else swallows several of these
tablets all together, or you think a child has
swallowed any of these tablets, contact your
doctor or pharmacist or hospital emergency
department immediately. Always take any tablets
left over with you, also the box and leaflet as this
will allow easier identification of the tablets.
The symptoms to be expected of overdose are
those of low sugar in the blood (hypoglycaemia)
Symptoms include sweating, pale colour of the
skin (pallor), hunger pangs, Increased heart
beats(tachycardia) and malaise. These
symptoms can be helped by taking glucose or
sweet drinks.
If you forget to take Gliclazide Tablets
If you forget to take a dose, take it as soon as
you remember. If it is almost time for your next
dose, do not take the missed dose and just carry
on as before. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Gliclazide Tablets
You should continue to take these tablets for as
long as your doctor tells you to as your diabetes
will not be controlled if you stop your medication.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gliclazide Tablets can cause
side effects, although not everybody gets them.
The most commonly observed side effect is low
blood sugar (hypoglycaemia). For symptoms
and signs see Section 2 - Take special care
and Section 6 - Further Information.
If left untreated these symptoms could progress
to drowsiness, loss of consciousness or possibly
coma. If an episode of low blood sugar is severe
or prolonged, even if it is temporarily controlled
by eating sugar, you should seek immediate
medical attention
If you experience any of below mentioned
side effects, stop taking the tablets and
contact your doctor immediately. The
symptoms generally disappear if the medicine
is stopped. Your doctor will decide whether to
stop your treatment.
●Abnormal liver function which causes yellowing
of the skin and eyes (jaundice).
●Inflammation of the liver (hepatitis).
●With sulphonylureas ( antibacterial medicine ),
cases of severe changes in the number of blood
cells and allergic inflammation of the wall of
blood vessels have been described. Symptoms
of liver impairment (e.g. jaundice) have been
observed which in most cases disappeared after
withdrawal of the sulphonylureas, but may lead
to life threatening liver failure in isolated cases.
The other possible side effects are as below.
●Digestive disorders: Abdominal pain or
discomfort, nausea, vomiting, indigestion,
diarrhoea and constipation. These effects are
reduced when Gliclazide tablets are taken with
a meal as recommended.
●Skin disorders: Skin reactions such as rash,
redness, itching, hives angioedema (rapid
swelling of tissues such as eyelids, face, lips,
mouth, tongue or throat that may result in
breathing difficulty) have been reported. The
rash may progress to widespread blistering or
peeling of the skin (for example, the potentially
fatal Stevens-Johnson syndrome or toxic
epidermal necrolysis), skin reactions to sunlight.
●Blood disorders: Decrease in the number of cells
in the blood (e.g. platelets, red and white blood
cells) which may cause paleness, tiredness,
being short of breath, prolonged bleeding,
bruising, nose bleeds, sore throat, mouth ulcers,
severe chills and fever. These symptoms usually
stop when the treatment is discontinued.
●Liver disorders: There have been isolated reports
of abnormal liver function which can cause yellow
skin and eyes. If you get this, see your doctor
immediately. The symptoms generally disappear
if the drug is stopped. Your doctor will decide
whether to stop your treatment.
●Eye disorders: Your vision may be affected for a
short time, especially at the start of treatment.
This effect is due to changes in blood sugar
levels.
As for other sulphonylureas, the following
adverse events have been observed: cases of
severe changes in the number of blood cells and
allergic inflammation of the wall of blood vessels,
reduction in blood sodium (hyponatraemia),
symptoms of liver impairment (e.g. jaundice)
which in most cases disappeared after
withdrawal of the sulphonylurea, but may lead to
life threatening liver failure in isolated cases.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE GLICLAZIDE
TABLETS
Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the original
package.
Do not use your tablets after the expiry date
stated on the label or carton.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Gliclazide Tablets contain
The active substance is Gliclazide. Each tablet
contains 80mg of gliclazide.
The other ingredients are lactose monohydrate,
pregelatinised maize starch, colloidal anhydrous
silica, magnesium stearate and purified talc (see
section 2 for Important information about some of
the ingredients of Gliclazide Tablets).
What Gliclazide Tablets look like and contents
of the pack
Gliclazide Tablets are white, round, flat,
uncoated, with bevelled edges debossed ‘GZ/80‘
with break line on one side and plain on the other
side.
They are available in blister pack of 28, 30, 56 or
60 tablets (Not all pack sizes may be marketed).
Additional information for the patient on
Gliclazide Therapy
In the first few weeks of treatment the risk of
having reduced blood sugar levels
(hypoglycaemia) may be increased. So
particularly close medical monitoring is
necessary.
Low blood sugar (Hypoglycaemia) may occur for
the following reasons:
●if you take meals irregularly or skip meals
altogether,
●if you are fasting,
●if you are malnourished,
●if you change your diet,
●if you increase your physical activity and
carbohydrate intake does not match this
increase,
●if you drink alcohol, especially in combination
with skipped meals,
●if you take other medicines or natural remedies
at the same time,
●if you take too high doses of gliclazide,
●if you suffer from particular hormone-induced
disorders (functional disorders of the thyroid
gland, of the pituitary gland or adrenal cortex),
●if your kidney function or liver function is
severely decreased.
If you have low blood sugar you may have the
following symptoms: headache, intense hunger,
nausea, vomiting, weariness, sleep, disorders,
restlessness, aggressiveness, poor
concentration, reduced alertness and reaction
time, depression, confusion, speech or visual
disorders, tremor, sensory disturbances,
dizziness, and helplessness.
The following signs and symptoms may also
occur: sweating, clammy skin, anxiety, fast or
irregular heart beat, high blood pressure and
sudden strong pain in the chest that may radiate
into nearby areas (angina pectoris).
If blood sugar levels continue to drop you may
suffer from considerable confusion (delirium),
develop convulsions, lose self control, your
breathing may be shallow and your heart beat
slowed down, you may become unconscious.
In most cases the symptoms of low blood sugar
vanish very quickly when you consume some
form of sugar, e.g. glucose tablets, sugar cubes,
sweet juice, sweetened tea.
You should therefore always carry some form of
sugar with you (glucose tablets, sugar cubes).
Remember that artificial sweeteners are not
effective. Please contact your doctor or the
nearest hospital if taking sugar does not help or if
the symptoms reoccurs.
Symptoms of low blood sugar may be absent,
less obvious or develop very slowly or you are
not aware in time that your blood sugar level has
dropped. This may happen if you are an elderly
patient taking certain medicines (e.g. those acting
on the central nervous system and beta
blockers).
If you are in stress-situations (e.g. accidents,
surgical operations, fever etc.) your doctor may
temporarily switch you to insulin therapy.
Symptoms of high blood sugar (hyperglycaemia)
may occur when gliclazide has not yet sufficiently
reduced the blood sugar, when you have not
complied with the treatment plan prescribed by
your doctor or in special stress situations). These
may include thirst, frequent urination, dry mouth,
dry itchy skin, skin infections and reduced
performance.
If these symptoms occur, you must contact your
doctor or pharmacist.
If you have a family history of or know you have
the hereditary condition glucose-6-phosphate
dehydrogenase (G6PD) deficiency (abnormality
of red blood cells), lowering of the haemoglobin
level and breakdown of red blood cells
(haemolytic anaemia) can occur. Contact your
doctor before taking this medicine.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex,
HA1 4HF, United Kingdom
This leaflet was last approved in 01/2016.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Latest Drug Information Updates

OzempicOzempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the treatment...

JulucaJuluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir...